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Labeling Process Management (LPM), Sr Associate

Albany,, NY
  • This will be a Hybrid Role. Requesting local candidates to San Francisco as the role will require the EW to be onsite, in the Lab at least 3 days a week. With remote work being available up to 2 days a week. Schedule will be contingent on workload.
  • Non Negotiables for the role are: A basic level of pathology/lab experience and Image Analysis Experience
  • The purpose of the Global Labeling Strategy and Compliance (LSC) group is to develop and maintain core labeling documents to provide quality product labels and drive global labeling strategy to ensure safe and effective use of products for patients and healthcare providers around the world.
  • As part of Global Labeling Strategy and Compliance, and under the supervision of the LPM management, the Labeling Process Management, Senior Associate supports the Labeling Process Management team to manage Labeling Process Management activities.

Principal responsibilities include, but are not restricted to:
Day to Day Responsibilities:
  • Support labeling activities associated with legal entity manufacturing change.
  • Collaborate with Local Affiliates, along with Regional Regulatory Affairs and Operations colleagues, to plan and implement label changes, ensuring compliance with labeling processes.
  • Process and system support.
  • Provide artwork source text and process support as necessary.
  • Participate in Labeling Submissions meetings to provide input on labeling processes.
  • Provide regional operational support for labeling.

Preferred Qualifications:
  • Degree in pharmaceuticals, natural science or medicine
  • Previous experience working in industry in support of global labeling
  • Project Management
  • Fluent in English (oral and written)
Top 3 Must Have Skill Sets:
  • Must have experience regional labeling/ artwork
  • Familiar with document management systems
  • Please review top skill sets
Basic Qualifications:
  • Master’s degree
  • Bachelor’s degree and 2 years of related experience
  • Associate’s degree and 6 years of related experience
  • High school diploma/GED and 8 years of related experience
Knowledge and Skills
  • Previous experience working in industry in support of Global Labeling, Regulatory.
  • Works well independently and within teams
  • Use of document management tools
  • Ability to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
  • Time and project management skills
  • Ability to take initiative and drive results
  • Tolerance for ambiguity
  • Proficiency in anticipating and resolving problems
  • Oral and written communication and presentation skills
  • Relationship management

PAY RATE : $47/Hr. on W2.

"This posting is for Contingent Worker, not an FTE"

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